Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
This is a 5-period crossover study. Each Treatment Period is 1 day. Subjects will receive a single dose of randomized study drug at each of the 5 Treatment Visits (Visits 2, 3, 4, 5, and 6), with a 3- to 7-day Washout Period between Treatment Visits.
Age
12–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Are at least 12 years of age and no older than 65 years
Have stable (for 6 months) physician-diagnosed asthma with historical documentation of the diagnosis
Must be receiving 1 of the following required inhaled asthma therapies listed below for at least the last 30 days; Only SABA, which is used as needed for rescue, or Low to medium doses of ICS (alone or in combination with LABA), used regularly as maintenance asthma therapy
Demonstrate acceptable spirometry performance (ie, meet American Thoracic Society \[ATS\]/European Respiratory Society \[ERS\] acceptability/repeatability criteria
Pre-bronchodilator FEV1 of ≥40 to \<90% predicted normal value after withholding SABA for ≥6 hours
Confirmed FEV1 reversibility to Ventolin, defined as a post-Ventolin increase in FEV1 of ≥15%
only 2 reversibility testing attempts are allowed
You may not be if
Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia)
Oral corticosteroid use (any dose) within 6 weeks
Current smokers, former smokers with \>10 pack-years history, or former smokers who stopped smoking \<6 months (including all forms of tobacco, e-cigarettes \[vaping\], and marijuana)
Life-threatening asthma as defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s)
Historical or current evidence of a clinically significant disease
Cancer not in complete remission for at least 5 years
Hospitalized for psychiatric disorder or attempted suicide within 1 year
Unable to abstain from protocol-defined prohibited medications during the study
Clareo Health | Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma
